MISSISSIPPI LEGISLATURE
REGULAR SESSION 2015
By:
To: Public Health and
Welfare
Senator(s) Harkins, Collins, Hill
SENATE BILL NO. 2485
(As Sent to Governor)
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AN ACT ENTITLED THE "RIGHT TO TRY ACT"; TO AUTHORIZE LICENSED
PHYSICIANS TO PRESCRIBE OR RECOMMEND CERTAIN INVESTIGATIONAL
DRUGS, BIOLOGICAL PRODUCTS OR DEVICES TO CERTAIN ELIGIBLE
TERMINALLY ILL PATIENTS; TO PROVIDE DEFINITIONS; TO AMEND SECTION
73-25-37, MISSISSIPPI CODE OF 1972, IN CONFORMITY; AND FOR RELATED
PURPOSES.
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MISSISSIPPI:
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SECTION 1.
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This section shall be known and may be cited
as the "Right to Try Act."
(2)
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(1)
For purposes of this section:
(a)
"Eligible patient" means a person who meets all of
the following requirements:
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(i)
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will lead to the person's death;
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(ii)
Has a terminal illness, or a disability that
Has considered all other treatment options
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currently approved by the United States Food and Drug
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Administration and all relevant clinical trials conducted in this
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state;
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(iii)
Has received a prescription or
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recommendation from the person's physician for an investigational
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drug, biological product or device;
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(iv)
Has given written informed consent, which
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shall be at least as comprehensive as the consent used in clinical
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trials for the use of the investigational drug, biological product
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or device or, if the patient is a minor or lacks the mental
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capacity to provide informed consent, a parent or legal guardian
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has given written informed consent on the patient's behalf; and
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(v)
Has documentation from the person's physician
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that the person has met all of the requirements of this
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subsection.
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(b)
"Investigational drug, biological product or
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device" means a drug, biological product or device, any of which
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are used to treat the patient's terminal illness, that has
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successfully completed phase one of a clinical trial but has not
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been approved for general use by the United States Food and Drug
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Administration and remains under investigation in a clinical
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trial.
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substances.
The term shall not include Schedule I controlled
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(c)
"Terminal illness" means a disease that without
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life-sustaining procedures will result in death in the near future
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or a state of permanent unconsciousness from which recovery is
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unlikely.
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(d)
"Written informed consent" means a written document
that is:
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(i)
Signed by the:
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1.
Patient;
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2.
Parent, if the patient is a minor;
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3.
Legal guardian; or
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4.
Patient advocate designated by the patient
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under the Uniform Health-Care Decisions Act, Section 41-41-201 et
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seq.; and
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(ii)
Attested to by the patient's physician and a
witness and that, at a minimum, includes all of the following:
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1.
An explanation of the currently approved
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products and treatments for the disease or condition from which
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the patient suffers;
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2.
An attestation that the patient concurs
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with his or her physician in believing that all currently approved
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and conventionally recognized treatments are unlikely to prolong
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the patient's life;
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3.
Clear identification of the specific
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proposed investigational drug, biological product or device that
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the patient is seeking to use;
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4.
A description of the potentially best and
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worst outcomes of using the investigational drug, biological
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product or device and a realistic description of the most likely
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outcome.
The description shall include the possibility that new,
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unanticipated, different, or worse symptoms might result and that
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death could be hastened by the proposed treatment.
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description shall be based on the physician's knowledge of the
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proposed treatment in conjunction with an awareness of the
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patient's condition;
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5.
The
A statement that the patient's health plan
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or third-party administrator and provider are not obligated to pay
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for any care or treatments consequent to the use of the
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investigational drug, biological product or device, unless they
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are specifically required to do so by law or contract;
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6.
A statement that the patient's eligibility
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for hospice care may be withdrawn if the patient begins curative
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treatment with the investigational drug, biological product or
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device and that care may be reinstated if this treatment ends and
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the patient meets hospice eligibility requirements; and
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7.
A statement that the patient understands
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that he or she is liable for all expenses consequent to the use of
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the investigational drug, biological product or device and that
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this liability extends to the patient's estate, unless a contract
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between the patient and the manufacturer of the drug, biological
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product or device states otherwise.
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(3)
A manufacturer of an investigational drug, biological
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product or device may make available the manufacturer's
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investigational drug, biological product or device to eligible
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patients under this section.
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This section does not require that a
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manufacturer make available an investigational drug, biological
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product or device to an eligible patient.
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(a)
A manufacturer may:
Provide an investigational drug, biological product
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or device to an eligible patient without receiving compensation;
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or
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(b)
Require an eligible patient to pay the costs of or
associated with the manufacture of the investigational drug,
biological product or device.
(4)
This section does not require a health care insurer to
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provide coverage for the cost of any investigational drug,
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biological product or device.
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provide coverage for an investigational drug, biological product
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or device.
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(5)
However, a health care insurer may
This section does not require the Mississippi Department
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of Corrections or any other governmental agency to provide
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coverage for the cost of any investigational drug, biological
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product or device.
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(6)
This section does not require a licensed hospital or
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nursing home to provide new or additional services, unless
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approved by the hospital or facility.
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(7)
This section does not require a licensed physician to
offer any investigational drug, biological product or device.
(8)
Notwithstanding any other provision of law to the
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contrary, no state agency or regulatory board shall revoke, fail
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to renew, or take any other action against a physician's license
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under Section 73-25-1 et seq., Mississippi Code of 1972, or
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against a pharmacist's license under Section 73-21-71 et seq.,
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based solely on the physician's or pharmacist's recommendation to
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an eligible patient regarding prescription for or treatment with
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an investigational drug, biological product or device.
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against a health care provider's Medicare certification based
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solely on the health care provider's recommendation that a patient
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have access to an investigational drug, biological product or
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device is prohibited.
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(9)
Action
If the clinical trial is closed due to lack of efficacy
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or toxicity, the drug shall not be offered.
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a drug, product or device taken by a patient outside of a clinical
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trial, the pharmaceutical company or patient's physician shall
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notify the patient of the information from the safety committee of
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the clinical trial.
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(10)
If notice is given on
Except in the case of gross negligence or willful
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misconduct, any person who manufactures, imports, distributes,
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prescribes, dispenses, compounds or administers an investigational
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drug or device to an eligible patient with a terminal illness in
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accordance with this section shall not be liable in any action
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under state law for any loss, damage or injury arising out of,
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relating to, or resulting from:
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(a)
The design, development, clinical testing and
investigation, manufacturing, labeling, distribution, sale,
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purchase, donation, dispensing, compounding, prescription,
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administration, or use of the drug or device; or
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(b)
(11)
The safety or effectiveness of the drug or device.
If a provision of this section or its application to
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any person or circumstance is held invalid, the invalidity does
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not affect other provisions or applications of this section that
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can be given effect without the invalid provision or application,
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and to this end the provisions of this section are severable.
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SECTION 2.
Section 73-25-37, Mississippi Code of 1972, is
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amended as follows:
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73-25-37.
(1)
No duly licensed, practicing physician,
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physician assistant, dentist, registered nurse, licensed practical
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nurse, certified registered emergency medical technician, or any
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other person who, in good faith and in the exercise of reasonable
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care, renders emergency care to any injured person at the scene of
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an emergency, or in transporting the injured person to a point
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where medical assistance can be reasonably expected, shall be
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liable for any civil damages to the injured person as a result of
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any acts committed in good faith and in the exercise of reasonable
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care or omissions in good faith and in the exercise of reasonable
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care by such persons in rendering the emergency care to the
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injured person.
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(2)
(a)
Any person who in good faith, with or without
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compensation, renders emergency care or treatment by the use of an
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Automated External Defibrillator (AED) in accordance with the
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provisions of Sections 41-60-31 through 41-60-35, as well as the
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person responsible for the site where the AED is located if the
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person has provided for compliance with the provisions of Sections
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41-60-31 through 41-60-35, shall be immune from civil liability
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for any personal injury as a result of that care or treatment, or
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as a result of any act, or failure to act, in providing or
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arranging further medical treatment, where the person acts as an
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ordinary, reasonably prudent person would have acted under the
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same or similar circumstances and the person's actions or failure
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to act does not amount to willful or wanton misconduct or gross
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negligence.
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(b)
A person who has not complied with the provisions
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of Sections 41-60-31 through 41-60-35, but who has access to an
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AED and uses it in good faith in an emergency as an ordinary
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prudent person would have done in the same or similar
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circumstances, shall be immune from civil liability for any
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personal injury as a result of an act or omission related to the
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operation of or failure to operate an AED if the person's actions
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or failure to act do not amount to willful or wanton misconduct or
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gross negligence.
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(3)
Any employee of a local public school district, a
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private school, or parochial school, trained in the administration
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of auto-injectable epinephrine, who provides, administers, or
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assists in the administration of auto-injectable epinephrine, in
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accordance with the provisions of Section 37-11-71, to a student
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believed in good faith to be having an anaphylactic reaction,
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shall be immune from civil liability for any personal injury as a
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result of that care or treatment if the employee's actions or
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failure to act do not amount to willful or wanton misconduct or
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gross negligence.
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(4)
The immunity from civil liability for any personal
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injury under subsection (2) of this section includes the licensed
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physician who authorizes, directs or supervises the installation
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or provision of AED equipment in or on any premises or conveyance
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other than a medical facility, the owner of the premises where an
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AED is used, the purchaser of the AED, a person who uses an AED
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during an emergency for the purpose of attempting to save the life
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of another person who is or who appears to be in cardiac arrest,
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and the person who provides the CPR and AED training.
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(5)
The immunity from civil liability for any personal
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injury under subsection (3) of this section includes the licensed
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physician who prescribes the auto-injectable epinephrine, the
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school district, or any other entity, that legally obtained the
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auto-injectable epinephrine, and the person who provides the
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training in the administration of auto-injectable epinephrine.
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(6)
The immunity from civil liability under subsection (2)
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and subsection (3) of this section does not apply if the personal
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injury results from the gross negligence or willful or wanton
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misconduct of the person rendering the emergency care.
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(7)
Except in cases of gross negligence or willful
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misconduct, civil immunity shall apply to any licensed physician
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or licensed pharmacist who prescribes or makes recommendation to
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an eligible patient regarding prescription for or treatment with
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an investigational drug, biological product or device under the
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provisions of Section 1 of this act, and the State Board of
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Medical Licensure and/or the State Board of Pharmacy, as the case
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may be, shall be prohibited from taking any adverse action against
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the license of such physician or pharmacist based solely on the
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physician's action under the provisions of Section 1 of this act.
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SECTION 3.
This act shall take effect and be in force from
and after July 1, 2015.
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ST: Investigational drugs; authorize physicians
to prescribe to certain eligible terminally ill
patients.
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